Diabetic campers test 'bionic pancreas'

OXFORD — An automated system that can check blood-glucose levels of a diabetic 12 times per hour, including while the person sleeps, will be tested on 32 campers here by summer's end.

The system also pumps to the patient insulin and glucagon, to lower and raise blood-glucose, respectively, through a "bionic pancreas device."

The U.S. Food and Drug Administration-approved trial is underway at the Clara Barton Camp for girls in Oxford. It will move to campers at Charlton's Camp Joslin for boys in the near future.

Boston University and Massachusetts General Hospital researchers are working on the automated blood glucose control program. They said they hope to submit the findings of the camp trial for scientific review this winter.

Engineers from BU, led by Edward Damiano, associate professor of biomedical engineering, developed the system, which uses frequent measurements of blood-glucose concentrations along with beneath-the-skin delivery of insulin and glucagon, as directed by a computer algorithm.

The monitoring system has already been studied in insulin-deficient pigs and adults with type 1 diabetes in a hospital research setting in Boston.

Type 1 diabetics' insulin-producing cells have been destroyed. Consequently, their glucagon-producing cells don't work correctly because they don't know what to do, said Dr. Steven J. Russell, the study's principal investigator and a physician in MGH's Diabetes Unit.

The automated system makes decisions about how much insulin and glucagon to give, and then sends that information into insulin and glucagon pumps via Bluetooth, the technology used for hands-free talk on cellphones.

The study's focus on children is an important milestone because 14 is the median age at which people are diagnosed with diabetes, Dr. Russell said.

The camp is about halfway through the four-week trial. The 16 boys have yet to have their turn.

The study could not accommodate all of the campers who volunteered to be part of the trial, Dr. Russell said.

During the first week, eight girls used the bionic pancreas device, and the other eight underwent their traditional care in the camp.

At the end of the week, the girl groups switched so the two different methods of blood glucose control can be studied.

Having type 1 diabetes is particularly challenging for children because they're growing, busy and active, and their sensitivity to insulin is changing, Dr. Russell said.

"What we wanted to do was have a way to test it in children outside of the hospital research setting, but that would also allow us to keep a pretty close eye on them to make sure they stay safe and allow us to collect all the data we would need to move the process forward with the FDA and other regulatory agencies," Dr. Russell said.

Traditionally, a patient should check his levels 12 times a day and use his insulin pump as needed, the doctor said.

But often patients don't check that frequently. They might do so before each meal and snack, and before bedtime. Kids will often check in the middle of the night, Dr. Russell said.

In rare, but "not vanishingly rare cases," children's levels lower to the point of them having seizures or brain damage or they don't wake up in the morning, he said.

"So having a system that never sleeps and is constantly checking and adjusting is something that we've wanted to have in the diabetes world for a long, long time, and this system does that," the doctor said.

At present, the system is "cobbled together" from different components, including iPhones for their computing capabilities. Building a final integrated system is a large investment, Dr. Russell said.

"We want to be able to demonstrate that this works well and this investment would be worthwhile," he said.

A downside of having multiple devices "talking to each other" is the occasional radio-frequency dropout.

With one camper Wednesday, there was a problem getting her Bluetooth to connect. This caused a temporary issue where the bionic pancreas wasn't able to "see" the pump try to send glucagon doses, he said.

But staff could see this developing on a computer screen and dealt with the hiccup.

"We're depending on (Bluetooth) for a pretty critical function," Dr. Russell said. "We would never use Bluetooth in a final device, let's put it that way."

The camper, Isabella Taylor of Saratoga Springs, N.Y., said the prospect of an automated system someday joining the diabetes care market, and being involved in a trial, was exciting and a source of pride.

"We're all really looking forward to it," Isabella, 15, said. "It's a little unfinished right now. There are things that we can be worked on, but there are always things that can be worked on. So it's great that they've got this far already as it is. We're all pretty proud."

The $1 million study of 12- to 20-year-olds was funded by the National Institute of Health and the Helmsley Charitable Trust.

Dr. Russell said the camp trial is expensive because of months of preparation, and there are at least five people employed to work around the clock. The project includes seven nurses, four doctors, about a half dozen monitors, and engineers.

They also had to build the systems, purchase $50,000 of glucagon and travel to the FDA a couple of times, among other expenses. Some people who don't have cars have to be put in hotel rooms for a night.

Next summer the group hopes to study 6- to 11-year-olds, he said.

Mr. Damiano, whose son was diagnosed with diabetes at 11 months old, had been working in applied mathematics and fluid dynamics, but when his son was diagnosed about 13 years ago, he started thinking about how he could apply his skills to solving diabetes problems.

He began working on the control algorithm to regulate insulin and glucagon automatically in experiments on pigs.

After listening to Mr. Damiano give a talk at the Joslin Diabetes Center, Dr. Russell said he asked him if he was interested in experimenting on humans, which they started in 2008.